DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant filed a response and amended claims 7-9 on 12/16/2025.
The claim objections and 112(b) rejection of claims 7-9 are withdrawn in view of amendments.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant primarily argues claim 1 limitation “a pressurized medical balloon comprising a plurality of layers in need of lamination” is a structural limitation directed towards the apparatus, related to the rejections overs Stephens. Applicant references MPEP 2115 and the cited court cases.
Examiner respectfully disagrees that the “the pressurized balloon” is a component of the apparatus. The “pressurized balloon in need of lamination” is a material worked upon, not a part of the machinery of the apparatus.
Applicant argues the resulting product is a laminated, unpressurized balloon, not the claimed “pressurized medical balloon comprising a plurality of layers in need of lamination”. Examiner notes the “pressurized balloon in need of lamination” is a preform of the laminated, unpressurized balloon, and operating the apparatus allows for forming the “pressurized balloon in need of lamination” into the laminated, unpressurized balloon.
Examiner directs Applicant to [0010], which recites: “a method of laminating a medical balloon having a plurality of layers in need of lamination is provided. The method comprises placing the medical balloon into a flexible receiver. The method further comprises pressurizing the medical balloon, and evacuating the flexible receiver.”
Furthermore, in the claims:
Claim 2 recites “an inflator for inflating the pressurized medical balloon”;
Claim 4 recites “a seal for sealing the pressurized medical balloon”;
Claim 11 recites “a heater for heating the pressurized medical balloon”.
Based on the disclosure, “a pressurized medical balloon comprising a plurality of layers in need of lamination” is not a structure of the apparatus but rather a material worked upon by the apparatus (e.g., inflated by operation of an inflator, pressurized by a pressurized fluid supplied, heated by a heater). It is evident that the apparatus, and its elements, perform functions on the pressurized medical balloon, such that the pressurized medical ballon is the material worked upon by the apparatus.
In regards to the rejections over Tilson, Applicant argues “the balloon 20 includes a solid mandrel, which does not make it "pressurized" in any way.”
Examiner respectfully disagrees. Tilson shows the balloon is pressurized as the the volume of the balloon is maintained even under pressure (Figure 67). Tilson teaches the balloon’s internal pressure is maintained by the mandrel, and mandrel can be deflated during removal [0430]. Therefore, it is evident that the mandrel is inflated and pressurized, thereby the pressurizing the balloon.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 11, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stephens (WO 2014/055180).
Regarding claim 1, Stephens teaches a lamination apparatus comprising:
a plurality of pressurized composite laminate stiffeners (Figures 12 and 21, item 32 and Page 12, ln 26-35);
an evacuated, flexible receiver in which the laminates are placed (Figures 6-8, item 48; Page 9, ln 10-30; and Page 12, ln 10-37).
Stephens does not teach a pressurized medical balloon comprising a plurality of layers in need of lamination.
However, inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (see MPEP § 2115).
Additionally, the cited prior art teaches all of the positively recited structure of the claimed apparatus. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function (see MPEP §§ 2114 and 2173.05(g)).
Given that the structure of the apparatus of Stephens is identical to the claimed apparatus, it appears that the apparatus of Stephens would be capable of laminating a pressurized medical balloon comprising a plurality of layers in need of lamination.
Regarding claim 2 and 3, Stephens teaches the apparatus as applied to claim 1, further including an inflator for inflating the laminates, wherein the inflator is connected to the laminate in the evacuated, flexible receiver (Figure 13, 15-19, item 52; Page 8, ln 19-35).
Regarding claim 4, Stephens teaches the process applied to claim 1, further including a seal for sealing the laminate (Figures 15-19, Page 4, line 10- Page 5, line 2; Page 11, 17-26; Page 12, ln 10-35).
Regarding claim 5, Stephens teaches the apparatus as applied to claim 1, wherein the evacuated, flexible receiver comprises a bag (Figure 15- 19, item 52; Page 8, ln 19-35).
Regarding claim 11, Stephens teaches the apparatus as applied to claim 1, further including an autoclave for curing the laminates (i.e., a heater for heating the laminate) (Page 8, ln 19-37).
Regarding claim 14, Stephens teaches the apparatus as applied to claim 1, further including an autoclave (i.e., heated pressure chamber) for receiving the laminates in the evacuated, flexible receiver (Figure 5).
Claims 12-13 is/are rejected under 35 U.S.C. 102 as being anticipated by Stephens (WO 2014/055180) with Kluge (“Modelling heat transfer inside an autoclave: Effect of radiation”, Journal of Reinforced Plastics and Composites, Volume 35, Issue 14, July 2016, Pages 1126-1142) applied as evidence only.
Regarding claim 12 and 13, Stephens teaches the apparatus as applied to claim 11, wherein the heater is an autoclave (Page 8, ln 19-37).
Stephens does not explicitly teach the heater comprises a convective heater, wherein the heater comprises a radiant heater.
Kluge teaches autoclave heating of fiber-reinforced polymer composites provide both convective and radiant heating (Abstract, Page 1127, 1131, 1133-1136,1141).
Accordingly, an autoclave as taught by Stephens would serve as a convective and radiant heater, as evidenced by Kluge.
Alternatively, claims 1, 5, 6, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilson (PG-PUB 2009/0299401).
Regarding claim 1, Tilson teaches a lamination apparatus comprising:
a pressurized medical balloon comprising a plurality of layers in need of lamination (Figure 67 and [00428]-[0429]); and
an evacuated, flexible receiver in which the pressurized medical balloon is positioned (Figure 67 and [00428]-[0429]).
Regarding claim 5, Tilson teaches the apparatus as applied to claim 1, wherein the evacuated, flexible receiver is a bag (Figure 67 and [00428]-[0429]).
Regarding claim 6, -- Tilson teaches the apparatus as applied to claim 1, wherein the evacuated, flexible receiver comprises opposed sheets of material between which the pressurized balloon is located (Figure 67, items 238a and 238b).
Regarding claim 11, Tilson teaches the apparatus as applied to claim 1, further including a heater for heating the pressurized medical balloon [0428].
Regarding claim 14, Tilson teaches the apparatus as applied to claim 1, further including a heated pressure chamber for reeving the pressurized medical balloon in the evacuated, flexible receiver [00428].
Alternatively, claims 12-13 is/are rejected under 35 U.S.C. 102 as being anticipated by Tilson (PG-PUB 2009/0299401), with Kluge (“Modelling heat transfer inside an autoclave: Effect of radiation”, Journal of Reinforced Plastics and Composites, Volume 35, Issue 14, July 2016, Pages 1126-1142) applied as evidence only.
Regarding claim 12 and13, Tilson teaches the apparatus as applied to claim 11, wherein the heater is an autoclave [0428].
Tilson does not explicitly teach the heater comprises a convective heater, wherein the heater comprises a radiant heater.
Kluge teaches autoclave heating of fiber-reinforced polymer composites provide both convective and radiant heating (Abstract, Page 1127, 1131, 1133-1136,1141).
Accordingly, an autoclave as taught by Tilson would serve as a convective and radiant heater, as evidenced by Kluge.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO 2014/055180), as applied to claim 1, in further view of Santoni (US 11,826,969).
Regarding claim 6, Stephens teaches the apparatus as applied to claim 1, wherein the evacuated, flexible receiver comprises a bag (Figure 15- 19, item 52; Page 8, ln 19-35), wherein in the vacuum bag may comprise of elastomeric material and is attached to the frame assembly (Page 9, ln 10-30).
Stephens does not teach the evacuated, flexible receiver comprises opposed sheets of materials between which the laminates are located.
Santoni teaches an apparatus for forming a fiber article comprises providing a first and second diaphragm in between which a fiber article is disposed, wherein the diaphragms are each connected to a frame (Figure 2 and 5a-5f). Santoni teaches the diaphragm may be elastomeric sheets, such as rubber or silicone sheets (Col 9, ln 37-42). Santoni teaches the frames brings the diaphragms in sealing engagement and provides an air-tight connection between the frames to draw vacuum between the diaphragm (Col 5, ln 18-42; Col 7, ln 40-63; Col 8, ln 40-67).
Both Stephens and Santoni are drawn to vacuum-based molding. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the single vacuum bag and single frame of Stephens with a pair of diaphragms and frames as taught by Santoni, a known suitable assembly for sealing and vacuum-molding a laminate.
Regarding claim 7, Stephens in view of Santoni teaches the apparatus as applied to claim 6, wherein each sheet of material is connected to a frame (Santoni, Figure 2a and 5a-5f; Col 5, ln 18-42; Col 7, ln 40-63; Col 8, ln 40-67).
Regarding claim 8, Stephens in view of Santoni teaches the apparatus as applied to claim 6, wherein a plurality of pressurized stiffeners are located between the opposed sheets of material (Santoni, Figure 2a and 5a-5f; Col 5, ln 18-42; Col 7, ln 40-63; Col 8, ln 40-67; Stephens, Figures 12 and 21, item 32 and Page 12, ln 26-35).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO 2014/055180) in view of Santoni (US 11,826,969), as applied to claim 8, in further view of Morris (US 8,293,051).
Regarding claim 9 and 10, Stephens in view of Santoni teaches the apparatus as applied to claim 8, wherein each pressurized stiffener is connected to the autoclave pressure through the manifold (Stephens, Figure 15; Page 11, ln 17-35; Page 12, ln 25-37).
Stephens in view of Santoni does not teach each pressurized stiffener is connected to a pressurized fluid supply, wherein the pressurized fluid supply comprises a manifold.
Morris teaches an inflatable bladder disposed inside an enclosure to form a hollow composite (Figures 7-12). Morris teaches the mandrel is inflated to counteract the autoclave pressure applied to the vacuum bag enclosing the composite preform (Col 5, ln 5-39 and Col 6, ln 6-30). Morris teaches the mandrel may be inflated with any fluid, such as gas or liquid (Col 4, ln 18-27 and Col 6, ln 6-10).
Both Stephens and Morris are drawn to the same field of endeavor pertaining to vacuum-based molding using inflatable mandrels. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the apparatus of Stephens, in particularly the supply sources of Stephens, with a pressurized fluid supply, a known suitable mechanism for inflating mandrels against autoclave pressure as taught by Morris.
Accordingly, one of ordinary skill in the art would naturally have been motivated to modify the manifold of Stephens in view Santoni and Morris to operate with the pressurized fluid supply to yield the predictable result of controlling the pressure in the mandrel as desired by Stephens and Morris.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO 2014/055180) in view of Santoni (US 11,826,969), as applied to claim 8, in further view of Perrow (PG-PUB 2011/0221093).
Regarding claim 9 and 10, Stephens in view of Santoni teaches the apparatus as applied to claim 8, wherein each laminate is connected to the manifold (Stephens, Figure 5 and 15).
Stephens in view of Santoni does not teach each pressurized stiffener is connected to a pressurized fluid supply, wherein the pressurized fluid supply comprises a manifold.
Perrow teaches an inflatable bladder for composite molding [0036]-[0039] [0051]. Perrow teaches regulating the pressure of an inflatable bladder with use of a manifold, wherein the manifold can have four ports: a supply from either air, liquid, or steam, an outlet with a differential pressure valve to maintain pressure in the blader, a pressure gauge, and a regulator/bleeder to control the pressure amount [0049].
Both Stephens and Perrow are drawn to the same field of endeavor pertaining to vacuum-based molding using inflatable mandrels. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the apparatus of Stephens, in particularly the supply sources of Stephens, with a pressurized fluid supply, a known suitable mechanism for inflating mandrels as taught by Perrow, to yield the predictable result of inflating the mandrel to counteract autoclave pressures.
Accordingly, one of ordinary skill in the art would naturally have been motivated to modify the manifold of Stephens in view Santoni and Perrow to operate with a pressurized fluid supply, as taught by Perrow, for the benefit of controlling the pressure of the inflator.
Alternatively, claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tilson (PG-PUB 2009/0299401), as applied to claim 1, in further view of Stephens (WO 2014/055180).
Regarding claim 2-4, Tilson teaches the apparatus as applied to claim 1, wherein the pressurized medical balloon is disposed on a mandrel [0428], and the mandrel is removed by deflating or by collapsing an internal structure [0430].
Tilson does not teach an inflator for inflating the pressurized medical balloon, wherein the inflator is connected to the pressurized medical balloon, and further including a seal for sealing the pressurized medical balloon in the evacuated, flexible receiver.
Stephens teaches a lamination apparatus comprising:
a plurality of pressurized composite laminate stiffeners (Figures 12 and 21, item 32 and Page 12, ln 26-35);
an evacuated, flexible receiver in which the laminates are placed (Figures 6-8, item 48; Page 9, ln 10-30; and Page 12, ln 10-37); and
a plurality of pressurizable bladders to be placed inside of the stiffeners to pressurize the bladder, thereby compacting the stiffeners (Page 3, ln 12- Page 5, ln 17),
a manifold for controlling the pressure (Figure 15; Page 11, ln 17-35; Page 12, ln 25-37); and
a seal for sealing the pressurizable bladders (Figures 15-19, Page 4, line 10 Page 5, line 2; Page 11, 17-26; Page 12, ln 10-35).
Tilson suggests different mandrels can be used, including a deflatable mandrel. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the apparatus of Tilson with inflators and manifold as taught by Stephens for the benefit of controlling the pressure within the mandrel to allow for desired compaction of the laminate and counteracting the autoclave pressure applied against the laminate.
Alternatively, Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tilson (PG-PUB 2009/0299401), as applied to claim 1, in further view of Santoni (US 11,826,969).
Regarding claim 7, Tilson teaches the apparatus as applied to claim 1, wherein the evacuated, flexible receiver comprises two membranes and a seal (Figure 67).
Tilson does not teach the evacuated, flexible receiver comprises opposed sheets of materials between which the laminates are located.
Santoni teaches an apparatus for forming a fiber article comprises providing a first and second diaphragm in between which a fiber article is disposed, wherein the diaphragms are each connected to a frame (Figure 2 and 5a-5f). Santoni teaches the diaphragm may be elastomeric sheets, such as rubber or silicone sheets (Col 9, ln 37-42). Santoni teaches the frames brings the diaphragms in sealing engagement and provides an air-tight connection between the frames to draw vacuum between the diaphragm (Col 5, ln 18-42; Col 7, ln 40-63; Col 8, ln 40-67).
Both Tilson and Santoni are drawn to vacuum-based molding. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the seal of Tilson with a frame as taught by Santoni, a known suitable assembly for sealing two membranes for providing a vacuum bag.
Regarding claim 8, Tilson in view of Santoni teaches the apparatus as applied to claim 7.
Tilson in view of Santoni does not teach a plurality of pressurized balloons located between opposed sheets of materials.
The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.04).
A mere duplication of the single pressurized medical balloon of Tilson with a plurality of pressurized medical balloon would have been obvious to one of ordinary skill in the art, as the duplication of parts would yield the predictable result of molding a plurality of laminates in a single vacuum cycle.
Alternatively, Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tilson (PG-PUB 2009/0299401) in view of Santoni (US 11,826,969), as applied to claim 8, in further view of Morris (US 8,293,051) and Perrow (PG-PUB 2011/0221093).
Regarding claim 9 and 10, Tilson in view of Santoni teaches the apparatus as applied to claim 8.
Tilson in view of Santoni does not teach each balloon is connected to a pressurized fluid supply, wherein the pressurized fluid supply comprises a manifold.
Morris teaches an inflatable bladder disposed inside an enclosure to form a hollow composite (Figures 7-12). Morris teaches the mandrel is inflated to counteract the autoclave pressure applied to the vacuum bag enclosing the composite preform (Col 5, ln 5-39 and Col 6, ln 6-30). Morris teaches the mandrel may be inflated with any fluid, such as gas or liquid (Col 4, ln 18-27 and Col 6, ln 6-10).
Both Tilson and Morris are drawn to the same field of endeavor pertaining to vacuum-based molding. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the apparatus of Tilson, in particularly the mandrels of Tilson, with mandrels coupled to a pressurized fluid supply, a known suitable mechanism for inflating mandrels against autoclave pressure as taught by Morris, to yield the predictable result of pressurizing the mandrel against autoclave pressure.
Perrow teaches an inflatable bladder for composite molding [0036]-[0039] [0051]. Perrow teaches regulating the pressure of an inflatable bladder with use of a manifold, wherein the manifold can have four ports: a supply from either air, liquid, or steam, an outlet with a differential pressure valve to maintain pressure in the blader, a pressure gauge, and a regulator/bleeder to control the pressure amount [0049].
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the apparatus of Tilson in view of Morris with a manifold configured to control the pressure of inflatable bladders, a known suitable mechanism for controlling the pressure of inflating mandrels as taught by Perrow, to yield the predictable result of inflating the mandrel to counteract autoclave pressures as desired by Tilson in view of Santoni and Morris.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANA C PAGE whose telephone number is (571)272-1578. The examiner can normally be reached M-F, 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phillip Tucker can be reached at 5712721095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANA C PAGE/Examiner, Art Unit 1745
/MICHAEL A TOLIN/Primary Examiner, Art Unit 1745